# K014022: Mri Line Marker

- Pathway: 510(k) (Traditional)
- Applicant: I.Z.I. Corp.
- Decided: Mar 4, 2002 after 88 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 25, 2022 · Class III · Z-1801-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi

## Indications for use
For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer plate accessories of stereotactic systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.

Source page: https://510kreport.com/device/K014022
Methodology: https://510kreport.com/methodology